Research

Stay up-to-date on the latest studies and bench-to-bedside therapies at Hopkins.

Clinical Trials

What is a Clinical Trial?

A clinical trial is a research study that involves people. Many clinical trials are performed to investigate the safety and effectiveness of new medications. However, researchers also conduct studies with people with CF to better understand basic lung biology, infections, symptoms and how all of these change over time. Download a brochure on clinical research. Trials that investigate the safety and effectiveness of medications in people are performed in a stepwise fashion. The process of testing new drugs takes several years and is separated into four phases:

Phase I clinical trials are designed to determine if a drug is safe for use in humans. These studies test a drug in a small number of people to determine the best method of giving the drug and how much can be given safely.

Phase II studies look at both safety and evidence of effectiveness. Determining the best dosing schedule is also part of a Phase II trial.

Phase III trials determine if a drug really works. As drugs progress through these three phases of clinical trials the number of patients needed increases dramatically. Phase III trials often require hundreds if not thousands of volunteers. These so-called multi-center trials are performed at several research centers at the same time.

Phase IV trials are performed immediately before as well as after a drug has been approved for use by the Food and Drug Administration (FDA). These are often large open-label studies investigating the safety of a drug. This means that all the patients in the study receive the drug; a placebo is not used. Phase IV trials are sometimes called post-marketing trials.

If you are interested in participating in a clinical trial at Johns Hopkins, please contact our Clinical Research Office at 410-955-1167 or complete the online form.

Nasal potential difference (NPD) measurement performed as part of a clinical trial.

Nasal potential difference (NPD) measurement performed as part of a clinical trial.

Ongoing Trials

Standardized Treatment of Pulmonary Exacerbations II (STOP 2)

PI: Natalie West, MD, MHS

CONTACT: 410-955-1167

PROTOCOL: IRB00090863

The Standardized Treatment of Pulmonary Exacerbations II (STOP 2) is a randomized, controlled, open-label study being done to learn more about CF patients who have a pulmonary exacerbation treated with IV antibiotics. The main purpose of this research is to study the effectiveness and safety of differing durations of IV treatment, given in the hospital or at home for a pulmonary exacerbation in adults with CF.

People 18 years of age and older with CF who are experiencing a pulmonary exacerbation that their doctor wants to clinically treat with IV antibiotics may join. Participation in this study will last approximately 24 to 35 days and will include 3 study visits at Johns Hopkins. Procedures at the Study Visits may include: physical exam, vital signs, height and weight, blood draws, pulmonary function testing, and sputum collection. We are open for enrollment and expect to enroll up to 100 subjects into this study at Johns Hopkins.

You will be compensated for your time. If you expect to be treated with IV antibiotics for a pulmonary exacerbation at home or in
the hospital and are interested, please let us know! We can discuss the study further and answer any questions you may have.

Contact the Research Team
Genetic modifiers of glucose metabolism in CF

PI: Scott Blackman, MD, PhD

CONTACT: 410-955-1167

PROTOCOL: IRB00062031

Contact the Research Team

Contact the Research Team

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